A Combined Single- and Multiple-dose, Open-label, Randomized, 6 x 3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability of Elinzanetant (BAY 3427080) in Healthy Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
研究概览
简要总结
The aim of this study is to examine the relative bioavailability of elinzanetant when administered in new oral formulations (treatment B and C) after both single and multiple oral doses, compared to its administration in soft gel capsule form (treatment A).
Study details include:
An ambulatory screening visit within 4 weeks prior to first treatment. Participants will be admitted to the ward on Day -1 of each period. On Day 1, either treatment B or treatment C will be administered fasted in the evening, followed by blood sampling for a 24-hour pharmacokinetic (PK) profile.
On Day 2, the multiple dosing starts 3 hours after a standardized dinner in the evening.
After the last dosing on Day 7, a complete PK profile for 24 hours will be collected.
If there are no medical objections, participants will be discharged from the study ward on Day 9 in the morning for a washout-out period of at least 10 days (240 hours after last dosing, after period 1 and 2) or, in period 3, after the follow-up examination.
The total duration of the study will be approximately 10 to 12 weeks for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participant between 18 to 65 years of age (inclusive), at the time of signing the informed consent form (ICF).
- •Participant is overtly healthy as determined by the investigator (including assessment of medical history, physical examination, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), body temperature, and clinical laboratory).
- •Body weight of at least 50 kg and body mass index (BMI) above or equal to 18.0 and below or equal to 32.0 kg/m² at screening.
- •Signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention(s) will not be normal.
- •Known or suspected allergy or hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication.
- •Febrile illness within 2 weeks before the start of the first study intervention.
- •History of clinically relevant seizures.
- •Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin, or gamma-glutamyl transferase (GGT) > 1.2 x upper limit of normal (ULN).
- •Previous (within 30 days before first administration of study intervention) or concomitant participation in another clinical study with study intervention(s).
研究组 & 干预措施
Sequence 5
Treatments are administered in sequence of B-C-A
干预措施: Treatment B (Drug)
Sequence 5
Treatments are administered in sequence of B-C-A
干预措施: Treatment C (Drug)
Sequence 6
Treatments are administered in sequence of B-A-C
干预措施: Treatment A (Drug)
Sequence 6
Treatments are administered in sequence of B-A-C
干预措施: Treatment B (Drug)
Sequence 6
Treatments are administered in sequence of B-A-C
干预措施: Treatment C (Drug)
Sequence 5
Treatments are administered in sequence of B-C-A
干预措施: Treatment A (Drug)
Sequence 4
Treatments are administered in sequence of C-B-A
干预措施: Treatment C (Drug)
Sequence 1
Treatments are administered in sequence of A-B-C
干预措施: Treatment A (Drug)
Sequence 1
Treatments are administered in sequence of A-B-C
干预措施: Treatment B (Drug)
Sequence 1
Treatments are administered in sequence of A-B-C
干预措施: Treatment C (Drug)
Sequence 2
Treatments are administered in sequence of A-C-B
干预措施: Treatment A (Drug)
Sequence 2
Treatments are administered in sequence of A-C-B
干预措施: Treatment B (Drug)
Sequence 2
Treatments are administered in sequence of A-C-B
干预措施: Treatment C (Drug)
Sequence 3
Treatments are administered in sequence of C-A-B
干预措施: Treatment A (Drug)
Sequence 3
Treatments are administered in sequence of C-A-B
干预措施: Treatment B (Drug)
Sequence 3
Treatments are administered in sequence of C-A-B
干预措施: Treatment C (Drug)
Sequence 4
Treatments are administered in sequence of C-B-A
干预措施: Treatment A (Drug)
Sequence 4
Treatments are administered in sequence of C-B-A
干预措施: Treatment B (Drug)
结局指标
主要结局
AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
时间窗: From Day 0 to Day 8
Cmax,md and Cmin,,md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C)
时间窗: From Day 0 to Day 8
次要结局
- AUC(0-24) after single dose in the evening under fasted condition (treatments A, B, C).(From Day 0 to Day 8)
- Cmax after single dose in the evening under fasted condition (treatments A, B, C).(From Day 0 to Day 8)
- Number and severity of treatment-emergent adverse events (TEAEs) after first study intervention until follow up(From first dosing up to Day 9)